Abdominal Aortic Aneurysms (AAA)
Conditions
Brief summary
A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).
Detailed description
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
Interventions
DEVICEAptus Endovascular AAA Repair System
EVAR (endovascular aneurysm repair)
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Infrarenal AAA with a maximum diameter ≥ 4.5 cm. * Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck. * Infrarenal AAA with a proximal neck internal diameter between 19-29 mm. * Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm. * Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm. * Bilateral iliac artery distal fixation sites ≥ 10 mm in length. * Bilateral iliac arteries with an internal diameter between 9 and 20 mm. * Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.
Exclusion criteria
* Myocardial infarction within past 10 weeks. * Active systemic infection. * Ruptured or leaking AAA. * Mycotic or inflammatory AAA. * Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes). * Concomitant TAA or thoracoabdominal aortic aneurysms. * Requires emergent AAA surgery. * Previous AAA repair. * Patients with a body habitus that would prevent imaging required by the study. * Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery. * Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair. * Dialysis dependent renal failure or creatinine \> 2.5 mg/dL. * Allergy to or intolerance of radiopaque contrast agents. * Patients with a known sensitivity or allergy to implant materials. * Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure. * Patients with history of bleeding diathesis or hypercoagulable condition. * Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone. * Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Composite Success Rate | 12 months | Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (\>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%. |
| Safety: MAE (Major Adverse Event) | 30 days | Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Aneurysm Rupture | 12 months | Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure |
| Effectiveness: Aneurysm Change | 12 months | Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of \>5mm) at 12 months post-index procedure |
| Effectiveness: EndoStaple Stent/Fracture | 12 months | Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure |
| Safety: SAE (Serious Adverse Event) | 5 years | Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure |
| Effectiveness: Type I Endoleak and Type III Endoleak | 12 months | Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure |
| Effectiveness: Thrombosis | 5 years | Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure |
| Effectiveness: Prosthesis Migration | 12 months | Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure |
| Effectiveness: Surgical Conversion | 12 months | Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AAA Repair System Aptus Endovascular AAA Repair System: EVAR | 155 |
| Total | 155 |
Baseline characteristics
| Characteristic | AAA Repair System |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 155 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 148 / 155 |
| serious Total, serious adverse events | 129 / 155 |
Outcome results
Primary
Effectiveness: Composite Success Rate
Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (\>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Composite Success Rate | 4 participants |
Primary
Safety: MAE (Major Adverse Event)
Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Safety: MAE (Major Adverse Event) | 3 participants |
Comparison: This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.p-value: <0.001Fisher Exact
Secondary
Effectiveness: Aneurysm Change
Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of \>5mm) at 12 months post-index procedure
Time frame: 12 months
Population: Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Aneurysm Change | 2 participants |
Secondary
Effectiveness: Aneurysm Rupture
Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Time frame: 12 months
Population: 143 reflects the number of subjects with data for the 12 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Aneurysm Rupture | 1 participants |
Secondary
Effectiveness: EndoStaple Stent/Fracture
Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Time frame: 12 months
Population: Denominator is number of subjects with adequate x-ray imaging available at 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: EndoStaple Stent/Fracture | 0 participants |
Secondary
Effectiveness: Prosthesis Migration
Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
Time frame: 12 months
Population: The denominator is the number of subjects with adequate CT imaging available at 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Prosthesis Migration | 0 participants |
Secondary
Effectiveness: Surgical Conversion
Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device.
Time frame: 12 months
Population: 143 reflects the number of subjects with data for the 12 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Surgical Conversion | 1 participants |
Secondary
Effectiveness: Thrombosis
Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Time frame: 5 years
Population: Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Thrombosis | 64 participants |
Secondary
Effectiveness: Type I Endoleak and Type III Endoleak
Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure
Time frame: 12 months
Population: Denominator is the number of subjects with adequate CT imaging available at 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Effectiveness: Type I Endoleak and Type III Endoleak | 2 participants |
Secondary
Safety: SAE (Serious Adverse Event)
Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AAA Repair System | Safety: SAE (Serious Adverse Event) | 129 participants |